The Adherus AutoSpray Dural Sealant delivers HyperBranch’s dural sealant to prevent leaks of cerebrospinal fluid after the surgical repair. The company’s spinal sealant had previously secured a CE Mark. With the latest CE Mark, the medical device developer can now start selling its surgical sealant system in Europe and other markets outside of the United States. The company is still seeking U.S. Food and Drug Administration approval of the system.
Durham, North Carolina-based HyperBranch has developed surgical sealants based on synthetic hydrogels. The biodegradable sealants break down slowly as the tissue heals. HyperBranch’s technology of adhering tissues to prevent leakage is based on chemistry research originally developed at Duke University by company co-founder Mark Grinstaff, who was a professor of chemistry, opthalmology and biomedical engineering at the university. CEO John Conn said in a statement that the technology provides a watertight seal and acts as an adhesion barrier that limits scarring, an advantage if subsequent surgery is required.
Privately-held HyperBranch now holds the CE Mark on five of its products so far. Besides the sealants for spine and cranial surgeries, the company also holds a CE Mark for an occular sealant and as well as a hernia mesh fixation product.